NanoMedicine Projects
NOCANTHER - April 16 - March 21
NOCANTHER
Project Details: Nanomedicine upscaling for early clinical phases of multimodal cancer therapy
Specific challenge: Promising pre-clinical nano-medicine proof-of-concns have been developed for the therapy of cancer, but their translation into clinical therapies remains a major challenge. An important bottleneck is up-scaling under Good Manufacturing Practice (GMP) conditions for the production of the nanomedicines from the pre-clinical laboratory scale to the quantity needed for clinical testing.
Scope: The aim is to translate promising novel nano-technology enabled therapies for cancer with pre-clinical proof-of-concept, from a pre-clinical lab stage up to Phase I clinical testing. The project shall start from an established pre-clinical proof-of-concept, with relevant efficacy and toxicity data. The project shall be focused on the translation process, so that ultimately new effective therapies can be introduced to the European healthcare market. An important aspect is the development of a pilot line for scaling-up the production of the nanomedicines and the quality control, taking into account GMP and medical regulatory requirements. Projects may include the later stages of pre-clinical testing and Phase 1 clinical testing, but the latter is not a requirement. Nanopharmaceuticals may be manufactured with either a top-down or a bottom-up approach, using for example self-assembling technology. Applicants must describe, according to industrial criteria, how the various barriers for advancing their new therapy to clinical application will be overcome, including technical, IPR, competitive, commercial and regulatory criteria, with efficacy and toxicity. Attention must be paid to clinical trial design and the foreseen research and commercial path to market introduction has to be well outlined.
The research is to be implemented from TRL 4/5 and target TRL 6/7.
Implemented as cross-KET activities.
Expected Impact:
*Potential major improvement in clinical cancer therapy, thereby providing enhanced quality of life for patients (taking gender and other diversities into account).*Potential reduced direct and indirect healthcare costs linked to the disease and its treatment.
*Accelerated introduction of new nanotechnology enabled cancer therapy, through robust manufacturing and quality control procedures for new nanotechnology enabled drugs.
NOCANTHER |
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Project Title |
Nanomedicine upscaling for early clinical phases of multimodal cancer therapy |
Summary |
1st April 16 - 31st March 21 |
Principal Investigator |
Prof. Yuri Volkov |
Funding Agency |
European Commission - Funded under H2020 - EU.2.1.2- Industrial Leadership |
Total Cost |
EUR 7 113 778,75 |
Objective |
During the last four years the Multifun Consortium (FP7 project Nº. 262943) has developed and validated distinct nanoformulations as therapeutic approach against pancreatic and breast cancer. These nanoformulations are based on magnetic iron oxide nanoparticles (MNP) multifuntionalised with a target peptide and an anticancer chemical drug, allowing for a synergistic therapeutic effect produced by the combination of intracellular drug delivery and magnetic hyperthermia. In particular, some of the designed formulations (patent filed PCT/EP2015/056631) have proven their efficacy, safety and non-toxicicty, in in vitro and in vivo studies, against the mentioned cancers, thus making them promising candidates to produce a novel nanomedicine therapy for cancer. NoCanTher aims at translating one of these nanoformulations to early clinical development for pancreatic cancer. To successfully reach this objective, we will concentrate our efforts in two main group of activities: • Nanomedicine up-scaling under GMP conditions: NoCanTher will scale up the manufacturing of the proposed nanoformulation from milligram-scale laboratory synthesis up to multigram-scale production to generate sufficient material for clinical and regulatory assays. To this aim, a GMP production line will be optimised and the relevant quality control will be conducted at the different stages of the up-scaling process. • Clinical trial: NoCanTher will include late preclinical parameter testing to raise a clinical treatment protocol, regulatory assays, as well as the design of the clinical trial and the preparation of the Investigational Medicinal Product Dossier (IMPD). This strategy will allow us to apply for Clinical Trial Authorisation (CTA) then, we will carry out a Phase I clinical trial. NoCanTher involves the participation of institutions from three different sectors (academia, industry, clinical) and from five different countries (Ireland, France, Germany, Spain and the UK). |
| Coordinator | Fundacion IMDEA Nanociencia
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| Participants | BIOPRAXIS RESEARCH AIE IMMUPHARMA PLC CHEMICELL GMBHFUNDACION CENTRO NACIONAL DE INVESTIGACIONES ONCOLOGICAS CARLOS III Universitätsklinikum Jena RESONANT CIRCUITS LIMITED FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA The Provost, Fellows, Foundation Scholars and the other members of Board, of the College of the Holy and Undivided Trinity of Queen Elizabeth near Dublin Université Paris Diderot-Paris 7 FUNDACIO PRIVADA INSTITUT D'INVESTIGACIO ONCOLOGICA DE VALL-HEBRON
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Conferences / Meetings |
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Multifun - July 2011 - May 2015
International Infrastructure / Projects / Collaborations
MULTIFUN
The MULTIFUN consortium focuses on the development and validation of new systems based upon minimal invasive nanotechnology for the early and selective detection and elimination of breast and pancreatic cancer with reduced side effects. The project will deploy a strategy based on the multifuntionalisation of magnetic iron oxide nanoparticles (MNP), combining diagnostic and therapeutic features against breast and pancreatic cancer and cancer stem cells.
The MULTIFUN therapeutic approach is multimodal, combining the nanoparticle heating induced by alternating magnetic fields with intracellular drug delivery in order to reinforce the therapeutic outcome. Since nanoparticles can be detected through magnetic resonance imaging (MRI), they can also be used as contrast agents for cancer cell detection. In this way, MULTIFUN combines therapeutic and diagnostic aspects leading to a potential “theragnostics” tool.
A key point of the project is to assess the safety and toxicicty of the developed nanoparticles. Thus, MULTIFUN includes a broad set of in vitro and in vivo toxicity and biodistribution tests in different animal models including mice, rats and pigs.
Finally, in order to improve the translation of the outcomes and their economic potential, the consortium also will study the scale-up of the production methods for the main components.
MULTIFUN |
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Project Title |
MultiFunctional nanotechnology for selective detection and treatment of cancer |
Summary |
MultiFun consortium is focused on the development of functionalized nanoparticles for early stage detection and treatment of breast and pancreatic cancer, where cancer stem cells are the key target. MultiFun strategy is based on the use of nanoparticles not only as a delivery agent but also as therapeutic and diagnostic-ones. The nanoparticle core is of iron oxide with superparamagnetic properties. Further, the nanoparticle is coated with a polysaccharide layer to render biocompatibility to the nanostructure. Additional functionalization steps to anchor ligands, antibodies, peptides and/or anti-cancer agents will allow to asses the utility of different nanostructure formulations as breast and pancreatic cancer diagnostic and therapeutic approaches. The treatment will be based on a multimodal strategy which combines magnetic heating with the cancer cell delivery of anticancer agents. The effect observed when magnetic nanoparticles are subjected to AC magnetic fields is an increase of nanoparticle temperature which is transferred to their surroundings. This effect is called magnetic heating. Cancer cells are well known to be sensitive to temperatures above 45ºC, and they could be effectively eliminated by applying a local magnetic heating. Moreover, since magnetic nanoparticles can be detected by MRI they can be also used as contrast agents. The simultaneous use of the nanosystem for both, therapeutic and diagnostic approaches is known as theragnosis leading to significant advantages with respect to traditional approaches which usually require different tools for diagnosis and treatment. |
Principal Investigator |
Prof. Yuri Volkov |
Funding agency |
European Commission |
Date from |
July 2011 |
Date to |
May 2015 |
Namdiatream - July 2010 - July 2014
The European dimension of the NAMDIATREAM Consortium is ensured by the involvement of 22 partners
International Infrastructure / Projects / Collaborations
AWARDED BEST FutureFlash! Best Project Competition
NAMDIATReaM
NAMDIATReaM is a truly interdisciplinary and Pan-european consortium that builds around 7 High-Tech SMEs, 2 Multinational industries and 13 academic institutions. NAMDIATREAM has successfully developed nanotechnology-based toolkit to enable early detection and imaging of molecular biomarkers of the most common cancer types (breast, lung and prostate cancer) and of cancer metastases, as well as permitting the identification of cells indicative of early-stage disease onset. The project is built on the innovative technology concepts of super-sensitive “lab-on-a-bead”, “lab-on-a-chip” and “lab-on-a-wire” nano-devices.
OUTPUTS FROM THE
LARGE-SCALE INVESTMENT
3 major international scientific conferences organised
290 scientific contributions as invited/active participants
20 workshops (13 scientific / 7 trade fair)
140 peer-review articles/proceedings/book chapters published
5 patents / 2 products
NAMDIATREAM |
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Project Title |
Nanotechnological toolkits for multi-modal disease diagnostics and treatment monitoring - NAMDIATREAM |
Summary |
NAMDIATREAM will develop a cutting edge nanotechnology-based toolkit for multi-modal detection of biomarkers of most common cancer types and cancer metastases, permitting identification of cells indicative of early disease onset in a high-specificity and throughput format in clinical, laboratory and point-of-care devices. The project is built on the innovative concepts of super-sensitive and highly specific "lab-on-a-bead", "lab-on-a-chip" and "lab-on-a-wire" nano-devices utilizing photoluminescent, plasmonic, magnetic and non-linear optical properties of nanomaterials. This offers groundbreaking advantages over present technologies in terms of stability, sensitivity, time of analysis, probe multiplexing, assay miniaturisation and reproducibility. The ETP in Nanomedicine documents point out that nanotechnology has yet to deliver practical solutions for the patients and clinicians in their struggle against common, socially and economically important diseases such as cancer. Over 3.2M new cases and 1.7M cancer-related deaths are registered in Europe every year, largely because diagnostic methods have insufficient level of sensitivity, limiting their potential for early disease identification. |
Principal Investigator |
Prof. Yuri Volkov |
Funding agency |
European Commission |
Date from |
July 2010 |
Date to |
July 2014 |
NAMDIATREAM presented at "Cluster Targeted Nanopharmaceuticals and Diagnostics European Union" (3rd November 2010) Brussels, Organised by the European Commission Reserach Directorate-General. |
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NAMDIATREAM- Prof. Yuri Volkov officially presented the outline of the FP7 Large NMP project in front of the European Commissioners for DG RTD, DG SANCO, NMP, the representative for EMEA, the participating at the European Technology Platform of Nanomedicine executive board, and industrial partners General Assembly (Milan 14th -15th October 2010 Prof. Gou'ko also presented his group's latest research findings at the meeting Details of the event can be found at: https://etp-nanomedicine.eu/events/ Programme available at: https://etp-nanomedicine.eu/events/ |
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CCAN-NanoMedic
CCAN-NanoMedic |
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Project Title |
Nanoparticle enabled in vivo diagnostics and drug delivery. |
Summary |
Biopolymer coated nanoparticles have a great potential both for diagnostics and drug delivery. The NANOMEDIC project will develop new nanoparticle enabled in-vivo diagnostic and drug delivery systems. The delivery systems involve: (i) nebulizer based technology for delivering drug payload to the epithelial lining of the lung and (ii) functionalized nanoparticle drug release structures, which can be utilized, for example, in catheter based delivery systems. |
Principal Investigator |
Prof. Yurii Gun'ko and Prof. Yuri Volkov |
Funding Agency |
Enterprise Ireland |
Scientific Presentations |
Conroy J., Verma N.K., Tormey S., Lyons P., Coleman J., O'Sullivan M., Kornfeld M., Kelleher D., Volkov Y. Biocompatibility analysis of surface modified magnetite and gold nanoparticles. Nanoweek Conference: Nanotechnology Research Excellence & Commercial Opportunities, 31st Jan-1st Feb, 2011, Kildare, Ireland. |
NanoBiohazard Assessment
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Project Title |
Multi-modal toxicology and biohazard assessment of nanomaterials and their enabled products |
Summary |
Nanomaterials and their enabled products are increasingly attracting global attention due to their unique physicochemical properties. However, because of the raising health and safety concerns, nano-products and their components require a rigorous toxicology and biohazard assessment. We have developed an in vitro, multi-modal, automated, simple, sensitive and robust experimental procedure to evaluate potential cytotoxicity that may be cause by nanomaterials and their enabled products. Utilizing this approach, we have analyzed the biocompatibility of silver nanowire based thin-films and various size silver nanowires on the cultured human cells. |
Principal Investigator |
Prof Jonathan N Coleman |
Funding agency |
SFI Funded CRANN - HP Collaboration |
Date from |
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Date to |
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| Scientific Presentations | Verma N.K., Conroy J., Lyons P., Coleman J., O'Sullivan M., Kornfeld H., Kelleher D., Volkov Y. Multi-modal toxicology and biohazard assessment of nanomaterial-based thin films. SNNI's 6th annual Greener nano 2011 Conference, GN11: Advancing Applications and Reducing Risks. 2nd-3rd may, 2011, Cupertino CA, USA. |
Conroy J., Verma N.K., Tormey S., Lyons P., Coleman J., O'Sullivan M., Komfeld H., Kelleher D., Volkov Y. An in vitro integrated ultrasensitive approach to biocompatibility analysis of silver nanowires. 3rd NanoImpactNet Conference: Building a bridge from NanoImpactNet to nanomedical research Feb 14, 2011, Lausanne, Switzerland. |
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| Publications | Mohamed B.M., Verma N.K., Prina-mello A., Williams Y., davies A.M., Bakos G., Tormey L., Edwards C., Hanrahan J., Salvati A., Lynch I., Dawson K., Kelleher D., Volkov Y. Activation of stress-related signalling pathway in human cells upon Si02 nanoparticles exposure as an early indicator of cytotoxicity. Journal of Nanobiotechnology, 2011 9:29 |
Dr Navin Kumar Verma presented part of the research findings entitled "Multi-modal toxicology and biohazard assessment of nanomaterial-based thin films" at SNNI's 6th annual Greener Nano 2011 conference, GN11: Advancing Applications and Reducing Risks. 2nd-3rd May, 2011, Cupertino CA, USA. Details can be found at: http://www.greennano.org/GN11 |
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| Dr Navin Kumar Verma's Poster for Multi-modal toxicology and biohazard assessment of nanomaterial-based thin films | |
Ms Jennifer Conroy presented part of the research findings entitled "An in vitro integrated ultrasensitive approach to biocompatibility analysis of silver nanowires" at the 3rd NanoImpactNet Conference: Building a bridge from NanoImpactNet to nanomedical research Feb 14th, 2011 Lausanne, Switzerland. Details can be found at: https://nanotechia.org/events |
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BioNanoInteract - Oct 2007 - June 2011
BIONANOINTERACT |
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Project Title |
BioNanoInteract: Interactions of engineered nanoparticles with biological systems-a rational basis for nanotoxicology and nanomedicine |
Summary |
We combine state of the art techniques, methodologies, skills and instrumentation from several scientific arena's in major Irish research centres to create discipline-independent platforms address key questions in nanotoxicology and nanopharmacology. Thus, we identify the routes via which nanoparticles enter and accumulate in living organisms, and connect this to representative cell-nanoparticle systems. Then using the most advanced methods of chemical, physical, biological and toxicological sciences we connect nanoparticle properties (in physiological conditions) to the mechanisms via which they interact with, and disrupt, cellular processes. We establish means and protocol via which every step of the programme will be controlled, eliminating the factors that currently cause irreproducibility. We emphasize novel unbiased assessments of intra - and inter-cellular processes after exposure to nanoparticles, enabling us to explore an extensive database of nanoparticle effects on the living human cells and will develop a new generation of nanotechnology-based tools for diagnostic and treatment applications |
Principal Investigator |
Prof. Yuri Volkov |
Funding agency |
Science Foundation of Ireland, |
Programme |
Strategic Research Cluster |
Date from |
Oct 2007 |
Date to |
June 2011 |